Common Cold, Congestion, Cough, Fever, Headache, Malaise, Pharyngitis, Rhinorrhea, Runny Nose, Sneezing, Sore-throat, Sore Throats Viral
Conditions
Keywords
Common Cold, Pharyngitis, Fever, Congestion, Rhinorrhea, Cough, Sore Throat, Malaise, Headache, Runny Nose, Sneezing, Inflammation
Brief summary
Upper respiratory infections (URIs) have long posed a significant burden to the US healthcare system. Well before the coronavirus disease of 2019 (COVID-19) pandemic they have been among the most common acute outpatient illnesses, causing 75-100 million physician visits each year on average, and costing the health care system billions of dollars annually. This double-blind randomized placebo-controlled study tested the efficacy of two anti-inflammatory throat sprays against placebo and against a throat spray taken in conjunction with 325mg of aspirin, a well-known systemically administered cyclooxygenase (COX) inhibitor. Participants having common cold symptoms lasting less than two days were enrolled and given treatment to administer at home. Various common cold symptoms were assessed and measured via clinically validated self-assessment scales. Participants were screened for influenza and COVID-19 before enrollment and were excluded if found positive.
Interventions
DRUGWintergreen Throat Spray and Aspirin Tablet
The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. Aspirin in a 325mg tablet
DRUGAspirin Throat Spray and Placebo Tablet
The liquid spray contained 6mg dissolved acetyl salicylic acid per dose, menthol, lactoferrin, lysozyme, aloe, and glycerin. Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients.
DIETARY_SUPPLEMENTWintergreen Throat Spray and Placebo Tablet
The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin. The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients.
OTHERPlacebo Throat Spray and Placebo Tablet
The placebo spray contained vehicle buffer, a sub-therapeutic dose of menthol, and a sweetener. The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients.
Sponsors
Econometrica, Inc.
Applied Biological Laboratories Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Otherwise healthy adults with cold symptoms including sore throat who do not meet any of the
Exclusion criteria
listed below, * who rate their sore throat at least a 3 on a 10-point scale, * who have had a sore throat for less than 48 hours by the time they complete the intake clinical trial manager (CTM) assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief of Sore Throat Pain | 36 hours | A time-weighted summed difference in pain intensity on the sore throat pain intensity scale (STPIS) after the first dose of medication (STPIS 1st entry Day 1 compared to STPIS 4th entry Day 2). On the STPIS, 0mm, the leftmost point of the line, represents no throat pain, and 100mm, the rightmost point of the line, represents the most severe throat pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Efficacy Against Common Cold Symptoms | 48 hours | Secondary endpoints will include changes to the Modified Jackson Score, measured from Absent=0, Mild=1, Moderate=2 to Severe=3, with a higher score representing worsening of various cold symptoms and a lower score signifying improvement of various cold symptoms. |
Countries
United States
Outcome results
None listed